FDA Probes Deaths Tied to Energy Drink

by David Pittman David Pittman,Washington Correspondent, MedPage Today
October 23, 2012

WASHINGTON -- Five deaths and a nonfatal heart attack have been linked to the super-caffeinated Monster Energy drinks and the FDA is investigating the connection, the agency said.

The probe was launched following six voluntary reports "as we do with every adverse event report with a death," FDA spokeswoman Shelly Burgess told MedPage Today. "We take it seriously and we're looking into it."

But at this point, there's no evidence or causal link to the adverse events and a product, Burgess added.

The FDA's adverse event reports became public this week after Maryland attorney Kevin Goldberg released them. Goldberg represents the family of a 14-year-old Maryland girl suing Monster in California state court, claiming the drinks led to the caffeine toxicity that killed her.

Anais Fournier went into cardiac arrest and fell unconscious shortly after she consumed two 24-0z. cans of Monster in a 24-hour period, according to the complaint filed last week. The cause of death was listed as cardiac arrhythmia due to caffeine toxicity.

Monster could not be reached for comment on either the FDA investigation or the lawsuit.

Energy drinks such as Monster, Red Bull, Rockstar, Full Throttle, and AMP contain three times the concentration of caffeine as sodas. A 16-oz. can of Monster Energy contains 160 mg of caffeine, roughly the same as almost five cans of soda.

Other ingredients, especially guarana, kola nut, yerba mate, and cocoa, may further increase the caffeine concentration.

Highly caffeinated energy drinks have been linked to many potential health problems, particularly in young people. A review published last year in Pediatrics found half of the more than 5,000 caffeine overdoses in 2007 were among people younger than 19.

Children with underlying health problems, including cardiovascular, renal, or liver disease; seizures; diabetes; mood and behavior disorders; and hyperthyroidism may be more vulnerable.

Potential drug interactions with certain energy drinks exist when they contain ingredients such as tryptophan, vinpocetine, yohimbine, and ginseng.

Burgess said the agency would only release the adverse event reports on the energy drinks through a request made under the Freedom of Information Act.

She said investigating adverse events can be difficult for the agency. All reporting of such events is voluntary and then finding the appropriate information to connect the outcome to the cause is tedious, especially when it involves tough-to-obtain medical records.

The FDA limits caffeine content in soft drinks, which are classified as food, but energy drinks do not fit under a specific classification, although they are often categorized as dietary supplements.

But Sens. Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) are trying to change that. The senators sent a letter to FDA Commissioner Margaret Hamburg, MD, in April asking for tighter limits on its regulation of such energy drinks.

Hamburg responded by noting that manufacturers choose to label their drinks as either a food or a dietary supplement, although the FDA may challenge such labeling in some cases; those labeled as foods are regulated differently from supplements.

"The agency is in the process of preparing a final guidance on this topic with the expectation that it will help both FDA and industry distinguish between beverages, on the one hand, and liquid dietary supplements, on the other," she wrote.

"Your letter did not address one of our greatest concerns, which included the potential interactions and cumulative effects of additives with stimulant properties in energy drinks with high levels of caffeine," the senators wrote in another letter sent to Hamburg last month. "We ask FDA to provide additional information on the safety of multiple additives with stimulating properties in energy drinks when used in combination and with caffeine."